BioScan’s LightWire Nears FDA, European Submissions

BioScan Technologies, a Yokneam, Israel firm developing a 0.014″ intravascular ultrasound guidewire for coronary and peripheral procedures, is planning to file a 510(k) submission to the FDA in the next two months, Medgadget has learned. Furthermore, the company expects to complete the CE Mark and ISO 13485 certification by the end of 2009.The Bioscan LightWire™ device, designed to be used in stent and other percutaneous coronary intervention (“PCI”) procedures, features an opto-acoustic fiberoptic probe that creates and receives ultrasound; hence it can provide important information about the size of coronary and peripheral arteries in real time. This is the smallest intravascular ultrasound system in the world. Our sources close to the company say that the first version of the device does not create a high resolution image, but measures the arterial diameter and stent diameter to improve the stent procedure, potentially eliminatingcomplications such as stent misplacement or mal-apposition to the arterial wall, which are largely responsible for the current 5% complication rate of the stent procedure.
More about the device from its web page:

Lightwire is a coronary guidewire that provides reconstructed images of the vessel’s internal structure during cardiac catheterization intervention (such as percutaneous transluminal coronary angioplasty, PTCA), atherectomy or stent placement.
LightWire also provides diagnostic information, including location and size of atherosclerotic plaque. It can be used to facilitate deployment of stents and other therapeutic devices, and to assess treatment results.
The ArteroScan™ console provides real time arterial wall visualisation to the interventional cardiologist. This allows easy and straightforward measurement of both lumen and vessel (External Elastic Membrane) dimensions
The Ultrasound measurement technique can be used to correctly size and position balloons and stents. The ArteroScan™ displays can be used to ascertain optimal stent apposition and deployment and verification and documentation of final procedure results.